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Wireless Image Transmitter Unit

by Olympus Medical Systems Corp.

510(k) K120278

Wireless Image Transmitter Unit is a medical device (FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Olympus Medical Systems Corp., cleared under FDA 510(k) K120278 on 10 Aug 2012, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120278 Date10 Aug 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GCJ
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K120278

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K120278
UDI-DISize and differences
ATTACHMENT FOR UWIT MAJ-2011
Olympus Medical Systems Corporation
MAJ-201104953170327735 —On the market
DVI CABLE MAJ-1945
Olympus Medical Systems Corporation
N3647500 / MAJ-194504953170305016 —On the market
WIRELESS RECEIVER UWIT-RX
Olympus Medical Systems Corporation
UWIT-RX04953170327711 —No longer on the market
WIRELESS TRANSMITTER UWIT-TX
Olympus Medical Systems Corporation
UWIT-TX04953170327681 —No longer on the market

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →